Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH

Official title

Bipolar Transurethral Enucleation of the Prostate With Preservation of Ejaculation in Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Overview

This prospective randomized controlled trial will compare ejaculation-preserving bipolar transurethral enucleation of the prostate with standard bipolar transurethral enucleation of the prostate in sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment. Participants will be randomly assigned to either ejaculation-preserving B-TUEP or standard B-TUEP. The study will evaluate preservation of ejaculatory function, erectile function, urinary symptom improvement, uroflowmetry outcomes, post-void residual urine, perioperative complications, and need for retreatment during follow-up.

Detailed description

Benign prostatic hyperplasia is a common cause of lower urinary tract symptoms in aging men. Surgical treatment is indicated when medical therapy fails or when symptoms remain bothersome. Bipolar transurethral enucleation of the prostate is an established endoscopic surgical technique for benign prostatic obstruction, but standard endoscopic prostate surgery may be associated with loss of antegrade ejaculation.

This study will evaluate whether an ejaculation-preserving modification of bipolar transurethral enucleation of the prostate can preserve ejaculatory function while maintaining effective relief of lower urinary tract symptoms. The ejaculation-preserving technique will preserve the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum. The control group will undergo standard bipolar transurethral enucleation of the prostate.

Eligible sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment will be randomized in a 1:1 ratio to ejaculation-preserving B-TUEP or standard B-TUEP. Sexual and urinary outcomes will be assessed using validated questionnaires and objective urinary parameters. Follow-up assessments will include ejaculatory function, erectile function, International Prostate Symptom Score, post-void residual urine, uroflowmetry, perioperative complications, and need for retreatment.

Interventions

• Procedure Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate
  Ejaculation-preserving bipolar transurethral enucleation of the prostate will be performed with preservation of the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum.
• Procedure Standard Bipolar Transurethral Enucleation of the Prostate
  Standard bipolar transurethral enucleation of the prostate will be performed according to the conventional surgical technique without preservation of the paracollicular tissue and the area approximately 1 cm proximal to the verumontanum.

Primary outcome measures

• Change in Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Function Score From Baseline to 6 Months [Time frame: Baseline and 6 months postoperatively]

Secondary outcome measures (5)

• Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Bother Score at 6 Months [Time frame: 6 months postoperatively]
• Preservation of Antegrade Ejaculation at 6 Months [Time frame: 6 months postoperatively]
• Change in International Index of Erectile Function-5 Score From Baseline to 6 Months [Time frame: Baseline and 6 months postoperatively]
• Change in International Prostate Symptom Score From Baseline to 6 Months [Time frame: Baseline and 6 months postoperatively]
• Change in Maximum Urinary Flow Rate From Baseline to 6 Months [Time frame: Baseline and 6 months postoperatively]

Eligibility criteria

Inclusion criteria

• Male patients with lower urinary tract symptoms secondary to benign prostatic obstruction after failed medical treatment for at least 3 months.
• Sexually active patients with a continuous relationship with the same partner.
• International Prostate Symptom Score of 8 or greater.
• Transrectal ultrasound-estimated prostate size between 40 and 100 cc.
• Eligible for bipolar transurethral enucleation of the prostate.
• Ability to complete the required sexual and urinary function questionnaires.
• Ability to provide written informed consent.

Exclusion criteria

• Preoperative sexual dysfunction.
• Preoperative ejaculatory dysfunction.
• Diagnosis or suspicion of prostate cancer.
• Neurological disorders affecting lower urinary tract or sexual function.
• Detrusor hypocontractility.
• Catheter-dependent patients.
• Patients with bladder stones.
• Inability or refusal to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Department of Urology- Beni-Suef University Hospitals — Banī Suwayf

Identifiers

NCT: NCT07629479 · FMBSUREC07092025EjBTUEP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗